Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Johns Hopkins University

Status: Completed

Conditions: Atrial Fibrillation; Radiofrequency Ablation

Treatments: Procedure: usual PV ablation; Procedure: Box isolation of pulmonary veins

Study type: Interventional

Funder types: Other

Identifiers

NCT01091597

NA_00008424

Details and patient eligibility

About

Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

Exclusion criteria

• Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

usual ablation

Active Comparator group

Description:

Wide-area circumferential ablation of the pulmonary veins

Treatment:

Procedure: usual PV ablation

Box isolation of the pulmonary veins

Experimental group

Description:

Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.

Treatment:

Procedure: Box isolation of pulmonary veins